NICE backs Gilead's Harvoni in draft guidance

Patients in England and Wales look set to get access to Gilead Sciences' new hepatitis C virus (HCV) therapy Harvoni after a positive review by the National Institute for Health and Care Excellence (NICE).

NICE has recommended Harvoni (sofosbuvir and ledipasvir) as a treatment option for some adults with genotype 1 or 4 but not for genotype 3 in the draft, which is open for comment until 23 March. Genotype 1 accounts for around 46 per cent of UK HCV cases, closely followed by genotype 3 on 43 per cent, with genotype 4 relatively uncommon at around 4 per cent of cases.

Harvoni is approved to treat genotype 3 HCV in combination with oral ribavirin, but NICE said the evidence does not indicate this regimen is a cost-effective use of NHS resources as the quality-adjusted life-year (QALY) costs are in excess of the £30,000 threshold.

NICE also backed the use of Gilead's Sovaldi (sofosbuvir) in final guidance published earlier this year for genotypes 1, 3, 4, 5 and 6, although NHS funding for the drug has been delayed until the end of July in order to prepare the infrastructure to provide the treatment – such as specially-trained staff at treatment centres.

The decision to delay funding beyond the usual 90-day deadline has been criticised by groups such as the Hepatitis C Trust. The charity's chief executive, Charles Gore, insists there is no need for major changes to HCV treatment provision to cater for Sovaldi and the decision has been taken purely on cost grounds.

There is no mention of such a funding delay with Harvoni, which, at £39,000 per 12-week course, is a little more expensive than Sovaldi's £35,000 price tag, but it does not need to be given alongside injectable interferon drugs and so can be given in a shorter treatment regimen.

The anticipated publication date for the Harvoni guidance is, however, before the block on NHS funding for Sovaldi is lifted.

Harvoni "offers the possibility of a shortened course of treatment - in some cases as little as eight weeks," commented Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation.

"This could make it more likely that people will seek treatment for their condition," she added, noting that this could have additional important benefits such as reducing transmission of HCV to people without the infection. That is particularly important because there is a relatively low diagnosis rate for HCV and a sizeable carrier population who do not know they are infected.

Public Health England (PHE) reported last year that hospital admissions for hepatitis C-related end-stage liver disease rose four-fold between 1998 and 2012 to reach around 2,400, with deaths up by the same margin to 428.